Systemic Variables in the Saliva of Children Undergoing L... | NCT01307163

Studies
Systemic Variables in the Saliva of Children Undergoing Liver Transplantation

NCT01307163

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Mar 2, 2011Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Liver Transplant

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
esti19

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2008Estimated

First Submitted Date

Jan 10, 2008

First Submission Date that Met QC Criteria

Mar 1, 2011

First Posted Date

Mar 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2011

Last Update Posted Date

Mar 2, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Saliva is used nowadays as a significant diagnostic tool due to the latest technological developments. The research compares two experimental groups; children after liver transplantation and a control group.

Our objective is to identify from all the parameters that are evaluated, the ones that differ between the two groups. If such parameters will be found and differ statistically, it will be possible to create a non invasive medical examination protocol, which will probably be much more complaint, and being so would help locate individuals in risk groups with the tendency to develop an end-organ liver disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children after a successful liver transplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

In this prospective study 60 subjects will be examined. Children and adolescents from Schnaidder's hospital for children after a successful liver transplantation will be characterized as the study group. As a control group, 32 healthy examinees in the same age group will be selected from the dental pediatric department at Hadassah hospital, Ein karem, Jerusalem

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization IRB		Jerusalem		12000	Israel